Aplidin - Dexamethasone in Relapsed/Refractory Myeloma (ADMYRE)

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Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Condition or disease

Intervention/treatment

Phase

Relapsed/Refractory Multiple Myeloma

Drug: plitidepsin + dexamethasoneDrug: dexamethasone

Phase 3

Detailed Description:

Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles).

plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.

Progression Free Survival (PFS) as per intention-to-treat (ITT) [ Time Frame: Estimated average: 5 months. From randomization to the first evidence of progressive disease or death due to any cause ]

To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM).

Secondary Outcome Measures
:

Response rate [ Time Frame: Every 4 weeks untill progression ]

Duration of Response [ Time Frame: Estimated average: 3 months. From the date of first documentation of response to the date of disease progression or death. ]

Overall Survival [ Time Frame: Estimated average: 9 months. From randomization to the first evidence of progressive disease or death due to any cause ]

Overal Survival (OS) is defined as the time from the date of randomization to the date of death or last contact

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age ≥ 18 years.

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2

Life expectancy ≥ 3 months.

Patients previously diagnosed with multiple myeloma

Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen.

Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available)

Women must have a negative serum pregnancy test

Voluntarily signed and dated written informed consent

Exclusion Criteria:

Concomitant diseases/conditions

Women who are pregnant or breast feeding.

Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM

Known hypersensitivity to any involved study drug or any of its formulation components